Position DMPK, Principal Scientist/Associate Director
Company ROME Therapeutics
Location Cambridge, MA
Reports to Director, Biology
Who We Are
ROME Therapeutics is developing novel therapies for cancer and autoimmune diseases by harnessing the power of the repeatome – vast stretches of uncharted genetic material that have long been dismissed as “junk DNA.” With several drug targets identified and multiple discovery programs underway, ROME is moving rapidly to leverage this new frontier in biology. To lead this exploration, ROME has assembled a team of world-class leaders across fields including oncology, immunology, virology and machine learning. ROME was launched in April 2020 and was incubated at GV, in collaboration with ARCH Venture Partners and Partners Innovation Fund. ROME is based in Cambridge, Mass. For more information, please visit www.rometx.com.
What You’ll Do
- Strategically design and lead ADME, PK and PD studies, critically analyze and interpret data, identify issues and help overcome experimental challenges
- Serve as DMPK representative, communicating results cross functionally to and help guide structural modifications of small molecules and biologics to improve ADME properties for lead optimization and development candidate nomination
- Establish PK-PD-efficacy correlations to guide preclinical study design, contribute to selection of preclinical tox species and develop toxicokinetic plan to support IND for oncology and inflammation programs
- Work with outside experts or consultants for questions beyond the candidate’s area of expertise
- Prepare human dose projections based on preclinical data to guide candidate selection.
- Independently lead IND enabling ADME/PK studies from protocol to final reports.
- Write and review technical reports, research protocols, SOPs, IND sections and scientific manuscripts for publication.
- Identify and qualify external vendors for ADME, PK, and BA work
- Ensure timely preparation of contracts; review and process invoices for approval.
- Oversee timely delivery of data and maintain complete and timely data archiving.
What You’ll Bring
- PhD in Pharmacokinetics, medicinal chemistry, plus >5 years industry experience OR BS in biology or chemistry, plus >10 years industry experience
- Strong scientific knowledge of drug metabolism of small molecule and biologics discovery and development programs
- Proven ability to drive drug discovery projects from discovery through candidate selection and IND
- Capable of working independently in a team environment across biology, pharmacology, toxicology, and clinical functions
- Familiar with principles of non-compartmental data analysis, PK software, and human dose projection techniques
- Experience with external vendor management such as CROs and consultants
- Solid grasp of ICH regulatory guidance documents relevant to ADME/PK activities supporting nonclinical development in the US and Europe
- Effective Communication skills
- Pro-active and resourceful problem solver
- Comfortable with the ambiguity of early-stage Life Science companies
- Ability to manage multiple complex projects simultaneously
- Strong cross functional collaboration skills with a focus on trust, credibility, and mutual respect
- Asking questions, being open to new ideas and embracing ambiguity will help make you successful in this role.
- Ability and willingness to be candid and genuine
- Proven track record of demonstrating functional expertise and following through on commitments.
- Comfortable working in a hybrid environment as needed.
- Vaccination against COVID-19 is mandatory, subject to medical and religious accommodations, and proof of vaccination must be provided to ROME
Who You’ll Work With
All Roman citizens exemplify our core values. Romans are encouraged to BE BOLD, DELIVER EXCELLENCE and to CARE DEEPLY in our pursuit of discovering and delivering medicines to patients in need. Relentless curiosity means that we continually strive to improve, learn, and grow by asking questions, seeking knowledge, and stretching beyond our comfort zone. We rely on each other to know our stuff, follow through and to ‘GSD – get stuff done’. We are inspired to operate with respect and kindness, valuing differences and authenticity.
COMPENSATION AND BENEFITS
ROME offers competitive compensation and benefits.
HOW TO APPLY
Please send a cover letter and a copy of your CV to firstname.lastname@example.org
ROME Therapeutics is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.